PITTSBURGH, June 19 /PRNewswire/ -- Cohera Medical Inc. today announced that data published in the July issue of Plastic and Reconstructive Surgery show the company's surgical adhesive, TissuGlu, was effective in preventing the formation of seroma in an animal abdominoplasty model.
Summarized in a paper titled "Lysine-Derived Urethane Surgical Adhesive Prevents Seroma Formation in a Canine Abdominoplasty Model," (Plast. Reconstr. Surg. 2008; Vol. 122, Issue 1: 95-102) the results demonstrated that TissuGlu successfully prevented the formation of seroma in a novel large-animal model designed to evaluate seroma formation. While the control side in all seven animals used in the study demonstrated large, clinically significant seromas, the side treated with TissuGlu showed little or no evidence of fluid accumulation. In addition, histologic analysis of tissue samples from the animals showed no signs of inflammation or foreign body reaction associated with the adhesive.
"I am impressed with the experimental data that demonstrate a clear ability of the adhesive to control seroma formation in this animal model," said J. Peter Rubin, M.D., founder and director of the Life After Weight Loss surgical body contouring program at the University of Pittsburgh and the lead author of the paper. "This adhesive shows strong potential for widespread applications in many surgical specialties."
Surgeons have expressed a strong need for a product that adheres tissue flaps to help prevent the fluid accumulation that occurs between tissue layers after surgery. Surgical adhesives available today fall into two categories: "superglue"-type products that are strong but cannot be used inside the body because they break down into toxic byproducts and "fibrin sealant" products that are biocompatible but create a weak bond and are expensive and difficult to prepare during surgery.
"Seromas have been a major problem for post-surgical patients," said Susan E. Downey, M.D., a board-certified plastic surgeon at the Pacific SurgiCenter in Santa Monica, Calif. "This study demonstrates a great animal model and the efficacious use of an adhesive to address this difficult problem."
"The results illustrate the potential efficacy of TissuGlu and helps support the movement of TissuGlu into human clinical studies, which we expect to initiate next year," said Patrick Daly, president and CEO of Cohera Medical. "Our goal is to introduce to surgeons a tissue adhesive that encompasses the desired strong and effective bonding properties in a safe, resorbable and easy-to-use formulation."
Seroma formation is a frequent complication of plastic surgery procedures such as abdominoplasty, with complication rates ranging from 15 percent to 52 percent. In 2007, approximately 148,000 abdominoplasty, or "tummy tuck," procedures were performed in the United States, according to the American Society of Plastic Surgeons.
About Cohera Medical
Cohera Medical Inc. is a Pittsburgh-based company that is developing a revolutionary line of wound management products and surgical adhesives. Cohera Medical's products are based on a unique chemical design that is purely synthetic, easy to use, biocompatible and fully resorbable. The company's lead product in development, TissuGlu, is a sprayable bonding agent for plastic surgery procedures. TissuGlu adheres flaps of tissue after surgical procedures, eliminating the spaces where fluid accumulates and reducing wound drainage. Cohera Medical is also developing surgical adhesives targeting mesh fixation and small bone fixation, which will fill similar market needs in both orthopedics and general surgery. For more information, visit http://www.coheramed.com. TissuGlu and the other Cohera products have not yet been approved for medical use by the Food and Drug Administration (FDA) in the US or by any other country's regulatory authority.
Certain statements made throughout this press release that are not historical facts contain forward-looking statements regarding the Company's future plans, objectives and expected performance. Any such forward-looking statements are based on assumptions that the Company believes are reasonable, but are subject to a wide range of risks and uncertainties and, therefore, there can be no assurance that actual results may not differ materially from those expressed or implied by such forward-looking statements.
|SOURCE Cohera Medical Inc.|
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